The efficacy of disease-specific nutritional support compared with usual treatment in hemodialysis patients

ISRCTN	ISRCTN56882109
DOI	https://doi.org/10.1186/ISRCTN56882109
Protocol serial number	100059, NL638, NTR698
Sponsor	Numico Research B.V. (The Netherlands)
Funder	Numico Research B.V.

Submission date: 19/07/2006
Registration date: 19/07/2006
Last edited: 08/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Jane McKenzie
Scientific

Numico Research B.V.
PO Box 7005
Wageningen
6700 CA
Netherlands

Phone	+31 (0)317 467800
Email	Jane.McKenzie@Numico-Research.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	The efficacy of disease-specific nutritional support compared with usual treatment in hemodialysis patients
Study acronym	Renilon 7.5 study.
Study objectives	The nutritional status of patients supplemented with Renilon 7.5 for three months will be improved compared with patients who receive the standard treatment. Nutritional status will be assessed by a significant improvement after three months of treatment by the following parameters: normalized protein catabolic rate (nPCR), serum albumin, serum pre-albumin, serum creatinine and dry-body weight.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	End-stage renal disease
Intervention	Duration of intervention: three months. Intervention group: standard therapy and in addition, a daily nutritional energy-dense (2 kcal/ml) supplement containing 7.5 g/100ml of demineralised whey protein and very low amount of minerals (especially phosphate) which provides 500 kcal of energy and 18.8 gram protein. Control group: all subjects in the control group received standard therapy.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Renilon 7.5
Primary outcome measure(s)	Nutritional status as assessed by: 1. nPCR 2. Serum albumin 3. Serum pre-albumin 4. Serum creatinine 5. Dry body weight.
Key secondary outcome measure(s)	1. Phosphate binder use 2. Quality of life 3. Dietary intake 4. Blood parameters 5. Nutritional status as assessed by subjective global assessment (SGA)
Completion date	01/09/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	88
Total final enrolment	86
Key inclusion criteria	End-stage renal disease patients on hemodialysis treatment: 1. Requiring thrice-weekly hemodialysis for at least three months 2. Stable disease (no recent hospitalizations except for minor access-related stays) 3. C-reactive protein <20 mg/l 4. nPCR <1.0 5. Informed consent
Key exclusion criteria	1. Inadequate dialysis (Kt/V <1.2) 2. Peritoneal dialysis in the last three months 3. Serum albumin >40 g/l 4. Body mass index (BMI) >30 kg/m^2 5. Use of any investigational drug 6. Nutritional supplementation within the last two months 7. Requiring complete enteral nutrition 8. Age <18 years
Date of first enrolment	01/09/2003
Date of final enrolment	01/09/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Numico Research B.V.,

Wageningen
6700 CA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2008	08/01/2021	Yes	No

Editorial Notes

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.